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NDC 69842-0166-09 Ultra Strength Gas Relief 180 mg/1 Details

Ultra Strength Gas Relief 180 mg/1

Ultra Strength Gas Relief is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by CVS PHARMACY, INC.. The primary component is DIMETHICONE.

MedlinePlus Drug Summary

Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 69842-0166-09
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	69842-0166
Product ID	69842-166_b766068a-d4af-452a-9838-1db86127026d
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Ultra Strength Gas Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Simethicone
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	180
Active Ingredient Units	mg/1
Substance Name	DIMETHICONE
Labeler Name	CVS PHARMACY, INC.
Pharmaceutical Class	Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part332
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69842-0166-09 (69842016609)

Pricing Information	N/A
NDC Package Code	69842-166-09
Billing NDC	69842016609
Package	5 BLISTER PACK in 1 CARTON (69842-166-09) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date	2018-02-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3d046c50-a22e-4689-8c42-cb43d282a908 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

Antigas

Uses

for the relief of

pressure and bloating commonly referred to as gas

Warnings

Keep out of reach of children.

Directions

adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician

Other information

store at controlled room temperature 15º - 30ºC (59º - 86ºF)
protect from heat and moisture

Inactive ingredients

FD&C yellow#6, gelatin, glycerin, purified water and white ink

Questions or comments?

Call: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

Ultra Strength Gas Relief

Simethicone 180 mg Antigas 50 Softgels

NDC 69842-166-09

*Compare to the active ingredient in Gas-X® Ultra Strength

INGREDIENTS AND APPEARANCE

ULTRA STRENGTH GAS RELIEF

simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-166
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	180 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	orange (clear)	Score	no score
Shape	capsule (oval)	Size	10mm
Flavor		Imprint Code	PC3
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69842-166-09	5 in 1 CARTON	02/08/2018
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	02/08/2018

Labeler - CVS PHARMACY, INC. (062312574)

Name	Address	ID/FEI	Business Operations
Establishment
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.		421293287	manufacture(69842-166) , analysis(69842-166)

Revised: 6/2018

Document Id: b766068a-d4af-452a-9838-1db86127026d

Set id: 3d046c50-a22e-4689-8c42-cb43d282a908

Version: 2

Effective Time: 20180607